EU product safety framework for advanced robots & autonomous systems

Felicia Stoica DG GROW

• Safety and liability - both considered in the design stage

• Accidents may or may not happen

• Improving safety prevents liability exposure

Basic rule

Case study Robots

Machinery Directive

Medical Devices Directives

Low Voltage Directive

Toys

Radio equipment Directive

Electromagnetic

Compatibility Directive

OSH Framework Directive

...others

Safety through

design and

manufacture

EU safety Regulatory landscape

Responsibilities

Importers (on certain cases)

Businesses/users that change the safety of a product (e.g. customising it)

Manufacturers that supply products for own use

Manufacturers that supply products on the market

The main responsibility for product safety falls on producers. This includes:

"Products cannot be made absolutely safe, but can be made as safe as they should be"

1. Safe design 2. Protective measures 3. Warnings & instructions

Principles of safety integration

The 3-step method for risks identified on intended use & foreseeable misuse

Robots safety legislation

General rules

Mandatory safety requirements

Technical specifications to meet the safety requirements embedded into EU laws or prescribed in European harmonised standards

Manufacturer is responsible for safety of robots placed on the EU market

(!) CE marking issued after applying all relevant EU legislation (e.g. safety, environment, etc)

Robots safety legislation

European harmonized standards (EN) are developed by the European Standardization Organizations on a specific request from the Commission

EN development is mainly industry driven

EN standards give presumption of conformity with the EU legislation only if published in the Official Journal of the EU

Robots: Safety via EN standards Robots safety legislation

General rules

Robots safety legislation

Robots safety legislation

Specific – Machinery Directive 2006/42/EC (MD)

• EU safety legislation based on new approach principles

• Policy objectives: free movement of highly safe products within the EU

• Voluntary use of European harmonised standards

• No requirements for involving third party entity for CE marking

Robots safety legislation

Specific – Machinery Directive 2006/42/EC (MD)

Machinery Directive EN safety standards for robots (HRC*) based or adapted on ISO standards

EN ISO 12100, Safety of machinery – General principles for design – Risk assessment and risk reduction

EN ISO 10218 Robots and robotic devices - Safety requirements for industrial robots (principles of protection in HRC)

EN ISO 13849-1:2008 Safety of Machinery - Safety-related parts of control systems

EN ISO 13482:2014 Robots and robotic devices - Safety requirements for personal care robots

Etc…

* HRC: human-robot collaboration

Robots safety legislation

Robots safety legislation

Specific – The Radio Equipment Directive 2014/53/EU (RED)

legislative framework for (i) the safety, (ii) the interoperability, (iii) the interconnectivity and (iv) the efficient use of the spectrum of radio equipment between 0 and 3000 GHz.

Additional delegated acts in Article 3(3) can cover a broad range of topics and can be proportionate as they can be applied to classes or categories of products. In more details: (a) radio equipment interworks with accessories, […];

(b) radio equipment interworks via networks with other radio equipment;

(e) radio equipment incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected;

(f) radio equipment supports certain features ensuring protection from fraud;

g) radio equipment supports certain features ensuring access to emergency services;

(i)radio equipment supports certain features in order to ensure that software can only be loaded into the radio equipment where the compliance of the combination of the radio equipment and software has been demonstrated.

Robots safety legislation

Specific – The Radio Equipment Directive 2014/53/EU (RED)

Robotics evolution State of the art and future trends (I)

Controlled, Predictable, Automated, Autonomous

No direct human control, Fully autonomous, Self-learning, Exhibit intelligent behavior

Internet of Things

AI Collaborative robots Industrial robots

Installed in factories Repetitive tasks -

autonomously Behind fences – no human

contact

Without cages - close proximity to humans

Professional service robots (healthcare)

Consumer robots (at home)

Software based robots - sophisticated sensors and

connectivity

Machinery Directive under evaluation: Check fitness for purpose to new emerging technologies (robotics, IoT, Industry 4.0)

Consultation activities finalized

- positive perception on how the Directive copes with innovation

- is generally seen as relevant in the face of changing technology over long periods (20+yrs)

- areas of concerns focused around innovations: digitisation, cybersecurity, software

Final report (SWD) to be published in Q1 2018

Potential revision.

Questions (e.g) under discussion in the machinery community (Machinery Directive WG)

- Psychological aspects of human-machine collaboration

- Classification of applications in robotics (possible new standardization request)

Robotics evolution - State of the art & future trends (II) Robotics evolution

State of the art and future trends (II)

MD and RED can be applied jointly, providing a thorough legislative framework for the safety of robotics products and autonomous systems, as part of IoT ecosystem.

The Liability Directive applies in conjunction to these Directives.

The Liability and the MD are being evaluated in order to verify whether there is a need to adapt some provisions to the new challenges of interconnected products (IoT)

Delegated Acts foreseen under the RED can provide further flexibility to follow the fast-evolving trends in the DSM.

Robotics evolution - State of the art & future trends (II) Robotics evolution

State of the art and future trends (III)

The essential requirements and the scope of the MD and the RED are already broad enough and the existing legislative framework may only need minor updates to tackle the challenges ahead.

• Improving safety reducing liability exposure

Thank you! Thank you!